Hyalolex Hand Sanitizer Vitamin E + Aloe Vera Sulfate + paraben Free 70% Ethyl Alcohol Antimicrobial

Drug Details [pdf]

HYALOLEX HAND SANITIZER- hand sanitizer liquid
India Globalization Capital Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hyalolex Hand Sanitizer Vitamin E + Aloe Vera
Sulfate + paraben Free
70% Ethyl Alcohol
Antimicrobial

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerol (1.45% v/v).
Hydrogen peroxide (0.125% v/v).
Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic, Antimicrobial

Purpose

Antiseptic, Hand Sanitizer, Antimicrobial

Use

To help reduce germs on the skin

Warnings

For external use only. Flammable. Keep away from fire or flame

Do not use

in or near the eyes. In case of contact, rinse eyes thoroughly with water

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use if irritation appears.

Keep out of reach of children.

Directions

Wet hands with product and briskly rub hands together until dry.
Supervise children under 6 years in use of this product.

Other information

Store between 20-25C (68-77F)
May discolor fabrics

Inactive ingredients

Purified water USP, Acrylate Copopyler, Glycerin, Carbomer, Propylene Glycol, Aloe Leaf Extract, Lemon Oil, Hydroxypropyl Methylcellulose, Tocopheryl Acetate

Package Label - Principal Display Panel

473 mL Bottle Label 473 mL NDC: 75540-253-16

HYALOLEX HAND SANITIZER
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75540-253
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL 1-STEARATE (UNII: 32I3MRN561)	1 mL in 100 mL
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)	1 mL in 100 mL
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)	1 mL in 100 mL
LEMON OIL (UNII: I9GRO824LL)	1 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL in 100 mL
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)	0.8 mL in 100 mL
WATER (UNII: 059QF0KO0R)	20.29 mL in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.05 mL in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	1 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 75540-253-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	04/30/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020	04/30/2023

Labeler - India Globalization Capital Inc (364601877)

Revised: 2/2023

Document Id: f45deacd-70d9-abfe-e053-2a95a90a0ef1

Set id: b4a1bd4f-0713-25df-e053-2a95a90abd1a

Version: 3

Effective Time: 20230210